The coverage with evidence development (CED) process employed by the U.S. Medicare program may suffer from underutilization, but the authors of a new article in Value in Health see the attendant problems as administrative in nature. The issues include, but are not limited to, a lack of predictability as to when a CED study would be required for coverage of a medical device.
Mark McCarty is a Regulatory Editor for Bioworld co., specializing in reporting on the latest developments and controversies in the regulatory landscape of the healthcare and biotechnology industries. With a keen eye for detail and a deep understanding of the regulatory processes, Mark provides insightful analysis and reporting on topics such as FDA guidance, postmarket surveillance, legal disputes, and industry trends.